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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K844714
Device Name SELECTRON LDR SELECTRON LOW DOSE RATE
Applicant
Radiochemical Co.
413 March Rd.
Kanata Ontario Canada,  CA
Applicant Contact SLOBODIAN
Correspondent
Radiochemical Co.
413 March Rd.
Kanata Ontario Canada,  CA
Correspondent Contact SLOBODIAN
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received12/03/1984
Decision Date 02/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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